Micardis (Telmisartan) - Indications and Dosage

INDICATIONS AND USAGE

Micardis® (telmisartan) tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

DOSAGE AND ADMINISTRATION

Dosage must be individualized. The usual starting dose of MICARDIS tablets is 40 mg once a day. Blood pressure response is dose related over the range of 20-80 mg (see CLINICAL PHARMACOLOGY , Clinical Trials ).

•   Special Populations: Patients with depletion of intravascular volume should have the condition corrected or MICARDIS tablets should be initiated under close medical supervision (see WARNINGS, Hypotension in Volume-Depleted Patients ). Patients with biliary obstructive disorders or hepatic insufficiency should have treatment started under close medical supervision (see PRECAUTIONS , General , Impaired Hepatic Function and Impaired Renal Function ).

Most of the antihypertensive effect is apparent within two weeks and maximal reduction is generally attained after four weeks. When additional blood pressure reduction beyond that achieved with 80 mg MICARDIS tablets is required, a diuretic may be added.

No initial dosing adjustment is necessary for elderly patients or patients with renal impairment, including those on hemodialysis. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored.

MICARDIS tablets may be administered with other antihypertensive agents.

MICARDIS tablets may be administered with or without food.

HOW SUPPLIED

MICARDIS tablets are available as white or off-white, uncoated tablets containing telmisartan 20 mg, 40 mg or 80 mg. Tablets are marked with the BOEHRINGER INGELHEIM logo on one side, and on the other side, with either 50H, 51H or 52H for the 20 mg, 40 mg, and 80 mg strengths, respectively. Tablets are provided as follows:

Micardis® (telmisartan) tablets 20 mg are round and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0597-0039-37).

MICARDIS tablets 40 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0597-0040-37).

MICARDIS tablets 80 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0597-0041-37).

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Tablets should not be removed from blisters until immediately before administration.

Distributed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA

Licensed from: Boehringer Ingelheim International GmbH, Ingelheim, Germany

©Copyright 2009, Boehringer Ingelheim International GmbH, ALL RIGHTS RESERVED

MICARDIS tablets are covered by U.S. Patent 5,591,762

Rev: January 2009

OT1200FL3008
090340194/5

IT12004B
10005385/02